FDA-Device2025-10-29Class II
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
SEDECAL SA
Hazard
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Sold states
US: CA, IL, and NJ
Affected count
14 units
Manufactured in
Pelaya, 9 Pol., Pol. Ind. Rio De Janeiro, Algete, Spain
Products
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0260-2026Don't want to check this manually?
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